Lower Back Biomechanics in Veterans With Non-Specific Low Back Pain

Completed

Conditions studied: Chronic Low Back Pain

In brief

Low back pain (LBP) is strongly associated with opioid consumption among Veterans, and improved clinical management of LBP is likely to reduce reliance on opioid among Veterans. Up to 60% of patients with an acute episode of nonspecific LBP experience either symptom persistence or symptom relapse within one year. This is likely an indication of a failure in addressing the underlying mechanisms of pain or initiation of a new etiology; both may stem from a mismatch between patients and treatments. The overall goal of this research is to develop, validate and implement measures that are relevant to known mechanisms of LBP, which can then be used to holistically gauge the health status of patients' lower backs beyond self-reporting of symptoms. More accurate measurements will help better match of patients with existing treatments or development of more effective new treatments. The specific objective of this study is to generate evidence in support of the feasibility of the investigators' methods for 1) the evaluation of relative contribution of lower back tissues to spinal loads, and 2) the investigation of the resultant spinal loads in Veterans with non-specific LBP. The investigators have developed a powerful set of tools for the comprehensive assessment of spinal loads and lower back mechanical behavior (MB), that will enable the investigators to examine the existence or development of abnormalities in spinal loads and lower back MB in three groups of Veterans with different experiences with non-specific LBP. These groups will include 1) Veterans with chronic, non-specific LBP and high level of disability (n=18), 2) Veterans with chronic, non-specific LBP and low level of disability (n=18), 3) asymptomatic Veterans without a recent history of non-specific LBP (n=18; serving as control group). Successful completion of this feasibility project will pave the way for future studies (merit grant applications) that will verify the role of abnormalities in lower back MB and spinal loads in the clinical presentation of LBP. Such an understanding has the potential to help the affected Veterans with disabling non-specific LBP. Specifically, measures of lower back MB and spinal loads can be used not only to identify Veterans with mechanical abnormalities in their lower back who are likely to experience LBP in the future, but also to guide novel integrated physical and psychological preventative treatments aimed at improved lower back mechanics. Ultimately, the goal and resultant improvement in clinical outcomes of treatment for non-specific LBP is to diminish reliance on opioids for the symptom management of particularly Veterans with chronic LBP.

Key facts

Study ID

NCT04249453

Run by

VA Office of Research and Development

People needed

23

Starts

2021-01-15

Expected to finish

2022-12-14

Last updated by the study team

2024-11-01

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age between 21 and 70 years old
• Body mass index between 22 and 32

You may not qualify if…

• Any spinal surgery [e.g., spinal fusion surgery]
• Any abnormalities in lower extremity joints due to disease or injury that would likely affects lower back mechanics [e.g., lower limb amputation or peripheral arterial disease]
• Any safety concern [e.g., pregnancy]
• Any medical condition for which we can't determine the impact of the investigators' experimental procedures. [e.g., we don't know whether our measurement instrument will affect pacemakers.]
• Can't complete the tolerability tests for sudden perturbation and stress-relaxation (see description given under "Risk versus benefits")]
• Inability to read or verbally comprehend English
• Unwilling or unable to comply with study protocol
• Retention of legal advice or an open / pending legal case related to LBP

Where it is running

• Lexington VA Medical Center, Lexington, KY — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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